Computerized System Validation jobs in Remote

Petersburg, Virginia

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Today

About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, near

Full-time

Data Analyst - AWS Cloud & Security

Hybrid in New York, New York

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18d ago

Our client a 3rd Generation Management Consulting Firm is s eeking a hands-on Data Analyst to support AWS-based cloud and security logging initiatives. The role focuses on designing log ingestion, parsing, normalization, and enrichment pipelines across multiple AWS services for delivery into a centralized analytics platform. Responsibilities Design and implement log ingestion from AWS services (CloudTrail, CloudWatch, VPC Flow Logs)Parse, normalize, and enrich log data for downstream analyticsB

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Contract

$50 - $80

Salesforce Administrator/Developer (Part-Time)

Remote or Washington, District of Columbia

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Yesterday

RESPONSIBILITIES: Kforce has a client in Washington, DC that is looking for a Salesforce Administrator or Developer with 3+ years of experience using Sales Cloud. Responsibilities: Execute independently on small and medium Salesforce enhancements, such as: * Creating new fields and objects * Updating page layouts * Building reports and dashboards * Develop automation using Salesforce Flows * Perform ad-hoc data loads (e.g., updating accounts from a CSV file) * Test your own work (no dedicated

Third Party, Contract

$65 - $80 hourly

Computer System Validation Engineer

Vacaville, California

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Today

Job Summary: s a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements. Roles & Responsibilities: Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), I

Full-time

Computer System Validation engineer

Vacaville, California

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Today

Summary : As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. Roles & Responsibilities: Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and

Full-time

Computer System Validation Analyst

Foster City, California

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Today

Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Develop change management

Full-time

Computer System Validation Engineer

Princeton, New Jersey

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Today

Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections. Roles & responsibility: Knowledge on FDA Guidance's and industry Standards Develop and execute validation plan

Full-time

CSV Engineer

Redwood City, California

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Today

Roles & Responsibilities: Right now, the CSV team is focused on UATs, periodic review, test scripts and change controls for their Medidata CTMS and IT ServiceNow Infrastructure projects. The focus is to have CSV support the ongoing CTMS. The client is currently bringing a new CTMS in house and just implemented ServiceNow in the last couple of months. The team consists of three employees in the CSV department. This group works closely with the IT Business Relationships team and will interact dail

Full-time

SAP GTS Consultant

Remote

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5d ago

Title: SAP GTS Lead Location: Remote Minimum of 10 years of experience designing, developing, testing, and deploying solutions in SAP with a focus on international business and you have a minimum of 3 years of direct experience with the SAP GTS module and/or SAP GTS E4HMust have upgrade experience with GTS E4H Experience solving complex international and multi-plant distribution scenarios, including Order Routing between plants, the import of good into the United States, and the export of goods

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Contract

Depends on Experience

Sr. CSV Engineer

Blue Ash, Ohio

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Today

Roles & Responsibilities: Lead the validation and compliance of multiple systems, including Historian connections, SAP integrations, and Warehouse Execution Systems (AizoOn, Swisslog), ensuring readiness for serialization L3 and L4 processes Collaborate closely with client teams and internal stakeholders to define requirements, support workflows, and ensure smooth system implementation Execute infrastructure qualification (both virtual and physical) and support system commissioning while adheri

Full-time

Business Analyst

St. Louis, Missouri

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Yesterday

RESPONSIBILITIES: Kforce has a client in Saint Louis, MO that is seeking a Business Analyst. Responsibilities: * Work with the Commercial Intelligence team to create and maintain BI tools that support Field Sales teams and Commercial leadership * Meet with stakeholders to gather and document requirements for new BI tools, communicate timelines and status updates, and ensure deliverables meet expectations * Combine data from various sources (Databricks, Excel, CSV, etc.) into a single data mode

Contract

$23 - $27 hourly

Computer System Validation Engineer

Bothell, Washington

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2d ago

Job Title: Computer System Validation Engineer Location: Bothell, WA (50% Onsite) Duration: 6 Months Work Type: Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution PURPOSE AND SCOPE OF POSITION: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, a

Easy Apply

Contract

$73 - $75

Senior CQV Engineer

Thousand Oaks, California

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Today

Job Summary : The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements Roles & Responsibilities: uthoring, editin

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

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Today

Roles & Responsibilities: Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Devel

Full-time

Validation Engineer

Birmingham, Alabama

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Today

Responsibilities: Develop URS, SIC and SRA for new and existing aseptic facilities and equipment. Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications. Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions. Ensure all documentation is compliant with regulatory requirements and internal qualit

Full-time

Senior Validation Engineer

Thousand Oaks, California

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Today

Job Description: This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements. The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient

Full-time

Delta-V Engineer

Wilson, North Carolina

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Today

Job Description: We are seeking two experienced Delta-V Engineers to join our team and work onsite. The engineers will act as owners' representatives and support the existing team. This role requires expertise in automation systems, specifically Emerson Delta V, and entails working within a biopharmaceutical or pharmaceutical manufacturing environment. Roles & Responsibilities: ct as an owner's representative onsite, supporting the team with expertise in Delta-V systems. pply knowledge of Emerso

Full-time

CSV Engineer

Portsmouth, New Hampshire

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Today

Job Description: The CSV Engineer will serve as an individual contributor responsible for ensuring compliance with industry regulations and standards while driving efficiency in site and process improvement projects. This role requires expertise in computer system validation, controls automation, and GMP documentation, with a focus on DeltaV and Syncade MES systems. The engineer will collaborate with the CSV team to identify roadblocks, assess risks, and implement best practices across critical

Full-time

CSV Engineer

Indianapolis, Indiana

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Today

Roles & Responsibilities: Play a client facing Compliance Lead role in projects, programs, and support work. Provide consulting and guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based right-sizing approach. Take ownership of assigned project/program/support responsibilities and deliver to committed timelines. Meet quality expectations as per defined contractual obligations to the client. Monitor, guide and drive off-site team

Full-time

Validation Engineer

Hillsboro, Oregon

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Today

Roles & Responsibilities: 10+ years. Experience with CSV, upgrades, enhancements, and operational support procedures. Demonstrated ability to understand, analyze and document complex business processes, translate business needs and functional requirements into technical or process-driven solutions. Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment, lead business users/stakeholders and DTE team members to complete assigned wo

Full-time

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Computerized System Validation jobs in Remote